Fasenra Shows Consistent Safety, Efficacy in Long-Term in Severe Eosinophilic Asthma Trial

AstraZeneca announced results from the Phase III extension BORA trial evaluating the long-term safety and efficacy of Fasenra (benralizumab) as an add-on maintenance treatment in patients with severe eosinophilic asthma who had previously completed one of the two pivotal SIROCCO or CALIMA Phase III trials.

In the BORA trial, Fasenra given for an additional 56 weeks showed a safety and tolerability profile similar to that observed in the placebo-controlled SIROCCO and CALIMA trials, with no increase in the frequencies of overall or serious adverse events. The improvements in efficacy measures observed with Fasenra in the SIROCCO or CALIMA trials were maintained over the second year of treatment. Patients who were treated with placebo in the SIROCCO and CALIMA trials and subsequently transitioned to Fasenra in the BORA trial experienced improvements in efficacy outcomes consistent with those observed for Fasenra-treated patients in the previous trials. Fasenra is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.

· 74% of patients with a baseline blood eosinophil count of 300 cells per μL or greater (the primary efficacy population in the Phase III trials) who received FASENRA every eight weeks continuously from SIROCCO or CALIMA and into BORA, were exacerbation-free in BORA in their second year of treatment and maintained improvements in lung function and asthma control.

· 65% and 66%, respectively, of patients with a baseline blood eosinophil count of 300 cells per μL or greater who received FASENRA 30 mg every eight weeks were exacerbation-free their first year of treatment in the one-year, predecessor SIROCCO and CALIMA trials (49% for placebo arms in both trials).

The BORA data will be presented today during a late-breaking oral session at the European Respiratory Society (ERS) International Congress 2018 in Paris, France.

"The BORA data are important news for patients with severe eosinophilic asthma who need a treatment with sustained efficacy to help control their disease, and with a safety profile that supports long-term use," Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said.

Dr. William Busse, Professor of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, and lead investigator on BORA, said: "As a clinician, I am excited by the BORA trial results, which provide confidence to patients with severe eosinophilic asthma and physicians that the positive outcomes they are seeing with FASENRA can be maintained over a second year of treatment. In FASENRA, we have a biologic treatment that can improve outcomes for these patients long-term."

The overall annual asthma exacerbation rate for patients with baseline blood eosinophil counts of 300 cells per μL or greater who received FASENRA every 8 weeks continuously was consistent with the predecessor SIROCCO and CALIMA trials (0.46 in BORA; 0.65 and 0.66 in SIROCCO and CALIMA, respectively). Overall improvements in lung function, asthma control, asthma-related and general health-related quality of life scores were maintained for patients who received FASENRA continuously and were improved for patients previously receiving placebo in SIROCCO or CALIMA. Near complete eosinophil depletion was maintained in patients who continuously received Fasenra.

The most commonly-reported adverse events (≥ 5%) in BORA were upper respiratory tract infection, worsening asthma, headache, bronchitis and acute sinusitis. The most commonly-reported adverse events in SIROCCO, CALIMA and ZONDA (≥ 5%) were headache and pharyngitis.

Fasenra is AstraZeneca’s first respiratory biologic and is approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and several other countries.

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